Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022115

Expand all

LAMICTAL XR (LAMOTRIGINE)
25MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022115
Product Number: 001
Approval Date: May 29, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL XR (LAMOTRIGINE)
50MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022115
Product Number: 002
Approval Date: May 29, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL XR (LAMOTRIGINE)
100MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022115
Product Number: 003
Approval Date: May 29, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL XR (LAMOTRIGINE)
200MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022115
Product Number: 004
Approval Date: May 29, 2009
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL XR (LAMOTRIGINE)
250MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022115
Product Number: 006
Approval Date: Jun 21, 2011
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LAMICTAL XR (LAMOTRIGINE)
300MG
Marketing Status: Prescription
Active Ingredient: LAMOTRIGINE
Proprietary Name: LAMICTAL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022115
Product Number: 005
Approval Date: Apr 14, 2010
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English